Cleared Traditional

Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

K150358 · Gold Standard Diagnostics · Microbiology
Nov 2015
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K150358 is an FDA 510(k) clearance for the Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, a Antigens, Nontreponemal, All (Class II — Special Controls, product code GMQ), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on November 12, 2015, 273 days after receiving the submission on February 12, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K150358 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2015
Decision Date November 12, 2015
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GMQ — Antigens, Nontreponemal, All
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

Similar Devices — GMQ Antigens, Nontreponemal, All

All 31
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K250249 · Gold Standard Diagnostics, LLC · Oct 2025
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
K201438 · Arlington Scientific, Inc. (Asi) · Oct 2020
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391 · Arlington Scientific, Inc. (Asi) · Nov 2018
ASI Evolution
K173376 · Arlington Scientific, Inc. (Asi) · Jun 2018
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
K000687 · Beacon Biologicals, Inc. · Jun 2000
SYNTHETIC VDRL ANTIGEN
K993633 · Centers For Disease Control and Prevention · Feb 2000

More from Gold Standard Diagnostics

View all
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · LSR · Mar 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · LSR · Mar 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295 · LSR · Mar 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296 · LSR · Mar 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K200023 · LSR · Apr 2020